Question

a pharmacy technician is preparing a non-sterile ointment. according to usp <795>, which of the following is the maximum beyond-use date for a non-aqueous formulation compounded from commercially available ingredients?

14 days
6 months
1 year
30 days

Explanation:

Identify the compounding type

Using the Nonsterile Compounding and USP 795 Regulations knowledge points

• The problem specifies preparing a non-sterile ointment.
• The formulation is non-aqueous and prepared from commercially available drug products.

Determine the beyond-use date

Using the Beyond-Use Dating knowledge point

• Under USP Chapter <795> guidelines for nonsterile compounded preparations, the maximum beyond-use date (BUD) for non-aqueous formulations is not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever is earlier.
• Therefore, the maximum default BUD is 6 months.

Answer:

• 14 days
• 6 months (Correct answer)
• 1 year
• 30 days